LINK Endo-Model Knee Prosthesis Segments Recalled for Out-of-Specification Defects
The FDA has recalled 13 LINK Endo-Model knee prosthesis femoral segments because they may not meet manufacturing specifications. The defects were discovered through customer complaints.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving an orthopedic prosthetic device with out-of-specification manufacturing defects. This qualifies as a risk-of-harm product where no injuries have been reported, but the non-conformance to specifications poses a potential risk of device failure in implanted patients.
Plain-English summary
The LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left is being recalled. The device segments may not meet manufacturing specifications. The manufacturing defect was discovered through customer complaints reporting non-conformance to specifications.
Affected units are distributed domestically across eight U.S. states: Alabama, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, and Texas. Internationally, affected devices are located in Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and the United Kingdom. A total of 13 units are affected.
The recalled product is identified by Item Number 15-2979/02 and UDI-DI 04026575328109. Patients with this device should contact their surgeon or physician to determine whether their implant is affected and what actions may be appropriate.
The recalled product
- Product
- LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Hazard
- device-failure
- out-of-specification
- structural-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Item No. 15-2979/02
- UDI-DI: 04026575328109.
Distribution
Distributed in 8 states:
- AL
- GA
- IL
- IN
- KS
- NJ
- NY
- TX
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